Argus Cognitive, Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared Neurora (510(k) K260064), a tool that gives clinicians objective behavioral measures to support the diagnosis of autism in children ages 18 months through 12 years.
Autism now affects 1 in 31 children in the United States, according to the Centers for Disease Control and Prevention (CDC). Yet the median age of diagnosis is nearly 4, and only about half of autistic children are evaluated by age 3.
Clinicians upload video and audio from a standard behavioral assessment to the Neurora portal. Neurora measures more than 100 vocal, facial and gaze biometrics and reports how closely the child’s behavior aligns with that of children with and without an autism diagnosis. Clinicians interpret the result alongside their other findings and professional judgment.
“We built Neurora to support clinicians evaluating children for autism,” said Attila Meretei, MD, CEO and Co-Founder of Argus Cognitive. “Neurora works inside the assessment clinicians already use, without protocol changes or proprietary hardware, and is fully automated. Our goal is to reinforce every diagnosis with robust, quantitative evidence.”
“I’ve trained clinicians in autism assessment for years, and every evaluation comes down to clinical judgment where autism is just one of several questions we are asking,” said Latha Valluripalli Soorya, PhD, BCBA, Co-Founder and Clinical Lead of Argus Cognitive and Director of the Autism Assessment, Research, Treatment and Services (AARTS) Center at Rush University Medical Center. “Neurora provides nuanced behavioral data, increases the confidence of observational data when collected by others, and facilitates clinician review of behaviors from the same session through the portal. The clinician still makes the call.”
Neurora’s development was supported by the National Institutes of Health (NIH) through a Small Business Innovation Research (SBIR) grant. Earlier research, published in Frontiers in Psychiatry in 2026, was conducted at Rush University Medical Center and Sago Clinical Research in Chicago, and in Doha at the Qatar Biomedical Research Institute (QBRI), in collaboration with the Shafallah Center. QBRI is part of Hamad Bin Khalifa University (HBKU), a member of Qatar Foundation.
Neurora’s most recent clinical study was conducted with partners including LSU Health Shreveport, Autism Testing 4 Kids (AT4K) and Ascend Behavior Partners.
“Neurora is a significant step forward in autism assessment, and the AT4K leadership and clinical teams are proud to have been part of its development journey,” said Michael Freytag, CEO and co-founder of AT4K. “Together, we look forward to advancing access to timely, high-quality autism evaluations and making a meaningful difference for the children and families we serve.”
Clinics and health systems interested in bringing Neurora to their practice can visit https://neurorahealth.com or contact contact@neurorahealth.com.
Indications for Use
Neurora is a Class II pediatric autism spectrum disorder (ASD) diagnosis aid indicated for the non-intrusive quantification and reporting of biometrics derived from video and audio recordings collected during behavioral assessment sessions to assist healthcare professionals in the diagnosis of ASD in patients aged 18 months through 12 years. Neurora is intended for use in conjunction with the diagnostic process and is not a stand-alone diagnostic tool. Learn more at https://neurorahealth.com.
About Argus Cognitive
Argus Cognitive, Inc., founded in 2016 and based in Hanover, New Hampshire, develops software as medical devices that give clinicians deeper insight from standard clinical workflows.
View source version on businesswire.com: https://www.businesswire.com/news/home/20261008763773/en/
Media gallery
